NCT03116763

Brief Summary

The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

6.1 years

First QC Date

March 31, 2017

Last Update Submit

November 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • TRANSITION-Q (measuring change)

    14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)

    Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post

Secondary Outcomes (14)

  • PedsQL Arthritis Module (measuring change)

    Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post

  • PROMIS Pain Interference (measuring change)

    Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post

  • Screen for Child Anxiety Related Disorders (measuring change)

    Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post

  • Center for Epidemiologic Studies Depression Scale Revised (measuring change)

    Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post

  • Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)

    Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post

  • +9 more secondary outcomes

Study Arms (2)

iPeer2Peer Mentorship

EXPERIMENTAL

In addition to standard care, youth in the experimental group will receive the iPeer2Peer program, a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with JIA aged 18-22 years who have learned to function successfully with their disease). Mentors will encourage participants to develop and engage in self-management skills and provide social support.

Behavioral: iPeer2Peer Mentorship

Control Group

ACTIVE COMPARATOR

The control group will receive standard care but without the iPeer2Peer program.

Other: Active Comparator: Control Group

Interventions

10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.

iPeer2Peer Mentorship

The control group will receive standard care but without the iPeer2Peer program.

Control Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • males and females 12-18 years old
  • rheumatologist-diagnosed JIA according to ILAR criteria
  • able to speak and read English
  • access to a computer, smartphone or tablet capable of using free Skype software (note: participants who do not have adequate Internet access will be provided with portable Internet sticks)
  • willing and able to complete online measures.

You may not qualify if:

  • significant cognitive impairments
  • major co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment
  • participating in other peer support or self-management interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

The IWK Health Centre

Halifax, Nova Scotia, Canada

Location

Children's Hospital - London Health Sciences

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Nishat F, Kelenc L, Berard R, Duffy C, Feldman B, Forgeron P, Huber AM, Luca N, Schmeling H, Spiegel L, Tucker L, Watanabe-Duffy K, Killackey T, Lalloo C, Wiles B, Nair A, Olaizola S, McDermott B, Tavangar F, Kohut SA, Stinson JN. Assessing the impact of the iPeer2Peer program for adolescents with juvenile idiopathic arthritis: a mixed-methods randomized controlled trial. Pediatr Rheumatol Online J. 2024 Dec 27;22(1):109. doi: 10.1186/s12969-024-01052-5.

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jennifer N Stinson, CPNP, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 17, 2017

Study Start

March 28, 2017

Primary Completion

April 16, 2023

Study Completion

April 16, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations